Penn SICCA Follow-up Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

This study will involve the collection of follow-up data for patients who previously participated in the Sjogren's International Clinical Collaborative Alliance (SICCA) study at the University of Pennsylvania. Clinical data and specimens will be collected from subjects with objective evidence of dry eye who were or were not diagnosed with Sjogren's syndrome at the time of their initial participation in the SICCA study. Specimens will be collected from participants which will include tears, saliva, whole blood, serum, DNA and possible labial minor salivary gland biopsies when indicated. All individuals will participate in a standard evaluation protocol including an oral, ocular and physical examination, objective tests for dry eyes and dry mouth and, whenever necessary, a labial minor salivary gland biopsy. The biopsy requirement is waived for those who have already had positive lip biopsies in the past.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Previously participated in the SICCA study at Penn

Be 18 years or older

Disqualifiers

Did not previously participate in SICCA study at Penn

Under the age of 18 years

Trial population

Subjects who meet the inclusion/exclusion criteria for this study will be contacted to ask if they would be willing to participate. All recruited participants, who participated in the previous SICCA study at the University of Pennsylvania will be identified.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Collection of specimens and clinical information

To collect specimens (saliva, tears, conjunctival cells, and blood) and clinical information on dry eye patients with or without Sjogren's syndrome

Time frame
2 years

Secondary outcomes

1

Ocular surface exam findings

Characterize the clinical features of the ocular and oral components of dry eye patients with or without Sjogren's syndrome.

Time frame
2 years
2

Serologic testing

Characterize the laboratory, including serologic (including autoantibodies), features of dry eye patients with or without Sjogren's syndrome.

Time frame
2 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: